Indonesia to resume sharing H5N1 avian influenza virus samples following a WHO meeting in Jakarta

27 March 2007 | Jakarta -WHO welcomes the news from the Minister of Health of Indonesia, who announced at a joint news conference today that the country would resume sharing of H5N1 avian influenza virus samples “immediately”. This commitment by the Government of Indonesia follows a two-day meeting organized by WHO in Jakarta on 26-27 March 2007.

Indonesia’s Minister of Health, Siti Fadilah Supari, has focused global attention on the fact that developing countries have supplied H5N1 virus to WHO Collaborating Centres for analysis and preparation for vaccine production, but that the resulting vaccines produced by commercial companies are likely to be unavailable to developing countries such as Indonesia. She called this system “unfair.”

At the same time, withholding viruses from WHO Collaborating Centres poses a threat to global public health security and the ongoing risk assessment for influenza, conducted by WHO Collaborating Centres.

WHO Collaborating Centres perform a number of key influenza-related public health activities, including:

determining if the virus has acquired human genes or made other significant changes;

identification of potential vaccine strains;

testing to determine if the virus remains vulnerable to the recommended class of antivirals;

tracking the evolution of the virus and its geographic spread; and

updating diagnostics tests which may be necessary because the H5N1 virus, like all influenza viruses, constantly mutates.

WHO has welcomed the attention that the Minister has focused on this issue and her concern for developing country needs. In order to address these concerns and to maintain sample sharing for risk assessment, WHO organized the Jakarta 26-27 March meeting entitled “High Level Technical Meeting on Responsible Practices for Sharing Avian Influenza Viruses and Resulting Benefits”.

Experts at the meeting included representatives from approximately 20 countries which have had H5N1 animal or human outbreaks; senior scientists, including directors of WHO Collaborating Centres; and potential funders, including representatives from the Asian Development Bank and the Gates Foundation.

"We have struck a balance between the need to continue the sharing of influenza viruses for risk assessment and for vaccine development, and the need to help ensure that developing countries benefit from sharing without compromising global public health security,” said Dr David Heymann, WHO’s Assistant Director-General for Communicable Diseases.

When the meeting ended today, the Minister of Health of Indonesia reviewed the recommendations and concluded that Indonesian viruses could once again be shared with WHO. The specific conclusions of the technical meeting include the following:

The centres will continue to transform virus into seed virus suitable for vaccine production.

This process will be documented in a revised Terms of Reference for the WHO laboratories.

Other agreed uses of the virus will also be outlined in the terms of reference - including the standard procedures for providing these seed viruses to vaccine manufacturers (which has been the practice for the last 50 years) - in a manner to be determined.

The meeting endorsed WHO’s activities to increase safe and effective pandemic vaccine access, including efforts to mobilize the financial support required to develop a vaccine stockpile and to develop guidelines for the equitable and appropriate distribution of stockpiled vaccines to countries if an influenza pandemic occurs.

At the meeting, WHO’s activities to strengthen national laboratory capacity, and to designate regional WHO H5 influenza reference laboratories in order to strengthen WHO’s global influenza surveillance activities, were strongly endorsed.

Finally, the meeting endorsed WHO's efforts to link vaccine manufacturers in developed and developing countries to speed the transfer of influenza vaccine manufacturing technology.

Transcript of today's news conference

The following is a partial, edited transcript of the comments made by Dr Heymann at the news conference held today in Jakarta at which Indonesia’s Minister of Health announced the resumption of virus sharing.

Dr Heymann: The details will be worked out in the terms of reference which will describe exactly what a Collaborating Centre can do with the viruses provided through surveillance. This will be a standard document developed by WHO and it will be developed with input from WHO’s member countries, of course. That document will, we believe, permit WHO to receive shared viruses for risk assessment, to develop non-commercial diagnostic tests and to characterize the viruses in addition to preparing seed strains for vaccine. Those seed strains will then be shared with pharmaceutical companies to develop vaccine, and that mechanism will be outlined in the terms of reference of the WHO Collaborating Centres.

How will vaccine be made available to countries from vaccine manufacturers?

Dr Heymann: That will be necessary for the countries to negotiate. WHO is not involved in financial negotiations, either in selling viruses or buying vaccines. Countries will negotiate bilaterally with vaccine manufacturers. We will certainly facilitate if countries are asking for support but it won’t be standard.

Further comments by Dr Heymann

WHO's best practices for influenza virus sharing were developed for seasonal influenza vaccine, which only has a market in the developed countries and a few of the developing countries. H5N1 vaccines are a totally different issue. We will now modify our best practices to ensure that they are transparent to the developing countries which are providing samples, and which have requested to share in the benefits resulting from those viruses. WHO will develop terms of reference to ensure this, and at the same time the Director-General of WHO is committed to work with the Chief Executives Officers from pharmaceutical companies and donors to develop a possible stockpile of vaccines for developing countries should they need vaccines. But this is only at an early stage of feasibility study.

The other main task of WHO is to make sure the world is secure if a pandemic has occurred.

I think that Indonesia has raised an issue that is very important. An issue which will broaden the dialogue and access to vaccines, and we are very grateful to the Minister for having shown us the way forward with the other 18 developing countries that are here in Jakarta – most of them are virus sharing countries. And our relationship with the Minister of Health has been positive throughout the four months we have been discussing virus sharing - since the very beginning of our discussion in November.

Now we will finalize the WHO best practices for virus sharing that will go to the World Health Assembly where all countries will debate it.

If countries want to negotiate for vaccines with companies, that's perfectly within their domain. Industrialized countries negotiate regularly for vaccines and developing countries can certainly do the same.

The Minister has indicated that Indonesia will share viruses with WHO immediately. We will be ready to accept them as soon as the Minister starts to send. We will treat them in a manner that has been agreed until the terms of reference are in place, which means we will develop vaccine seed viruses and will share the virus with manufacturers after consultation with the Health Minister.

WHO looks out for the public health security of the world. The Indonesia virus strain may be very important one day. If we learn that those strains are important we will work with the Government to get those seed viruses into vaccine production in a transparent manner because our job is to make sure of the public health worldwide is not endangered, and we will do that.

All other delegates of the meeting have agreed to continue sharing the virus as they have been doing in the past.